China’s Walvax Biotechnology Co., Ltd (SHE: 300142) has announced the efficacy interim results of a Phase III clinical study for its RQ3013, a bivalent mRNA vaccine based on the S protein chimera of Alpha/Beta SARS-CoV-2 variants. The study provides crucial data on the vaccine’s performance as a sequential booster in the context of the ongoing COVID-19 pandemic.
Design and Purpose of the Phase III Study
The pivotal, regulatory Phase III study is designed to assess the protective efficacy, safety, and immunogenicity of RQ3013 as a sequential booster in individuals aged 18 and above who have completed three doses of COVID-19 inactivated vaccines. The main results indicated that during the Omicron variant’s epidemic period, RQ3013 demonstrated superior protection against COVID-19 infection of any severity for people aged 18 and over, compared to the control vaccine, meeting the World Health Organization’s (WHO) statistical superiority evaluation standard for placebo control trials.
Safety and Efficacy Findings
The primary symptoms of adverse reactions were fever, pain at the vaccination site, and headache, with most cases being mild (grades 1 and 2). There were no serious adverse events (SAE) related to the study vaccine, indicating good safety. Additionally, RQ3013 showed protective efficacy and safety for the elderly population (aged 60 and above), a demographic particularly vulnerable to severe COVID-19 outcomes. The vaccine’s protective efficacy fully meets the predetermined evaluation standards for clinical trials, highlighting its potential role in public health strategies.
Clinical Trial Approval and Progress
RQ3013 obtained clinical trial approval in China in August 2022, marking a significant step in the development of this mRNA vaccine candidate. The positive interim results from the Phase III study further underscore the vaccine’s potential contribution to global health efforts against COVID-19.-Fineline Info & Tech
